Screening for Developmental Delay in Early Childhood 2016 · Screening for Developmental Delay 7 ....
Transcript of Screening for Developmental Delay in Early Childhood 2016 · Screening for Developmental Delay 7 ....
Putting Prevention
into Practice
Canadian Task Force on Preventive Health Care
Groupe d’étude canadien sur les soins de santé préventifs
Screening for Developmental Delay in Early
Childhood 2016
Canadian Task Force on Preventive Health Care
(CTFPHC)
Dr. Patricia Parkin
Use of slide deck
• These slides are made available publicly as an educational support
to assist with the dissemination, uptake and implementation of the
guidelines into primary care practice.
• Some or all of the slides in this slide deck may be used in
educational contexts.
• The Screening for Developmental Delay Guideline was published
online March 28, 2016.
• Guideline is also available in Canadian Medical Association Journal
and on CTFPHC website: http://canadiantaskforce.ca/
2
CTFPHC DD Working Group Members
Task Force Members:
• Marcello Tonelli (Chair)
• Patricia Parkin
• Brett Thombs
• Paula Brauer
• Kevin Pottie
Canadian Paediatric Society
• Denis Leduc*
*non-voting members
3
Public Health Agency of Canada:
•Anne-Marie Ugnat*
•Alejandra Jaramillo Garcia*
•Wendy Martin*
•Marianna Ofner *(part of ASD-GC & ASD-AC)
•Sarah Connor Gorber* (PHAC/CIHR)
•Lesley Dunfield (previously with PHAC)
CTFPHC DD Working Group Acknowledgements
4
Members of the McMaster Evidence Review and Synthesis Centre:
•Rachel Warren
•Meghan Kenny
•Donna Fitzpatrick-Lewis
•Maureen Rice
•Muhammad Usman Ali
•Andy Bayer
•Sharon Peck-Reid
•Donna Ciliska
•Diana Sherifali
•Parminder Raina
•Clinical expert: Dr. Teresa Bennett
•ERSC Peer-reviewers: Dr. Alice Carter, Dr. Sharon Smile, Dr. Isabel Smith,
Dr. Lisa Hartling, Dr. Brian Reichow, Dr. Leslie Anne Campbell
Overview of Presentation
• Introduction to CTFPHC
• Background on Developmental Delay
• Methods for Guideline Development
• Recommendations and Key Findings
• Implementation of Recommendations
• Conclusions
• Questions and Answers
5
Canadian Task Force on Preventive Health
• The CTFPHC is an independent panel of primary care clinicians and
methodologists that develop recommendations on clinical preventive
services in primary care
– Expertise in prevention, primary care, literature synthesis, critical appraisal
• Mandate is to develop and disseminate clinical practice guidelines for
primary and preventive care, based on systematic analysis of scientific
evidence
– Intended to support application of evidence to practice and policy
– The CTFPHC recommendations focus on primary and secondary preventive services
Primary prevention: prevention of a target condition in healthy patients
– Secondary prevention: directed to asymptomatic individuals who have risk
factors for a condition or preclinical disease but who do not have clinically
evident disease
• CTFPHC uses a standard, transparent process to review and
synthesize evidence, weigh the balance of benefits and harms, and
make recommendations (GRADE system) 6
Background Developmental Delay
Guideline
• Developmental delay (DD) refers to significant delay in achieving
age-expected norms within any of the following domains: gross &
fine motor skills, speech-language, cognition , social and personal
skills, and activities of daily living
• DD may be transitory or sustained
• Children with sustained DD are at higher risk for learning difficulties,
behavioural problems, and functional impairments later in life
• There is considerable interest in the possibility that early
identification and intervention might improve health outcomes
among children with DD
• Therefore, the CTFPHC assessed the evidence on:
– the effectiveness of population-based screening for DD in primary care
– the accuracy of screening tools to identify undetected DD, and
– the effectiveness of behavioural interventions for DD.
8
Screening, Surveillance and Case Finding
• There is a great variation in terminology related to the detection of
developmental delay which can lead to misunderstandings
• Screening: refers to the use of a standardized tool to detect
developmental delay in populations where there are no overt signs
suggestive of possible DD and no concerns about development
• Developmental surveillance: is often used to describe the ongoing
monitoring of development, identification of risk factors, and elicitation of
parental concerns
• Case finding: refers to the identification of DD in populations that are at
increased risk of developmental delays and often does not involve the
use of a specific tool
• Developmental surveillance, though a common term in developmental
paediatrics, is what the CTFPHC would normally consider to be part of
standard clinical practice for children
9
Developmental Delay 2016 Guideline
• This guideline provides recommendations on screening for
developmental delay in a primary care settings – It does not offer guidance about surveillance, case finding or diagnosis
• This guideline applies to screening children aged 1 to 4 years with
no apparent signs of DD and whose parents and clinicians have no
concerns about development. – These are children for whom there is no concern about sequential acquirement of
age-appropriate developmental milestones for gross and fine motor,
social/emotional, language, and cognitive domains.
– Milestone ages should be based on the oldest age by which the skill should have
been achieve
• This guideline does not apply to children:
− Whose development is being closely monitored because of risk factors such as
premature birth or low birth weight
− Whose parents, caregivers or clinicians suspect there may be a delay in
development or atypical development
− Have signs suggestive of developmental delay 10
Methods for DD Guideline
• Work lead by Developmental Delay Work Group 5 CTFPHC members
& 1 member of Canadian Paediatric Society (1 CTFPHC member also with CPS)
• Established key questions, analytic framework, clinical and patient
important outcomes (research protocol)
• Commissioned an independent systematic review & quality
assessment of evidence
• Formulated recommendations based on a comprehensive
assessment of the balance of benefits and harms of screening,
treatment, accuracy of screening tests, patient values and
preferences, and resource considerations
• All members of CTFPHC reviewed and approved each phase of
guideline development process
• CTFPHC sent guideline for external peer and stakeholder review
• CMAJ also carried out an independent peer review process 12
Research Questions
• The systematic review for screening and treatment of developmental
delay included:
– 5 key research questions
• Effectiveness of screening, incidence of harms of screening,
effectiveness of treatment, etc.
– 3 contextual questions
• Cost effectiveness and feasibility, values and preferences of
primary caregivers, etc.
• Outcomes of interest:
– improvement to gross and fine motor skills, speech-language, and
cognition and performance, academic performance, adaptive
functioning, overall quality of life, mental health, survival, and
functionality as an adult.
• For more detailed information please access : www.canadiantaskforce.ca
13
Evidence Review Analytic Framework
14
Screening for DD
Treatment for domain specific Dev
Delay
Treatment for Dev.
Delay and ASD
Children aged 1 to 4 with no
known developmental
concerns
Harms: stigma,
parental anxiety, false positives &
consequences
For screening: Improved cognitive
function
For screening & treatment
Improved cognitive function
For treatment for
Dev delay: Improved cognitive
function
For treatment for domain specific
Dev delay: Improved
speech/language, gross and fine motor skills,
adaptive function performance &
cognition
For screening Improved academic performance, QoL,
mental health, survival, functioning as adult*
For screening &
treatment: Improved academic performance, QoL,
mental health, survival, functioning as adult*
For screening &
treatment: Improved academic performance, QoL,
mental health, survival, functioning as adult
For treatment for
domain specific delays: Improved academic performance, QoL,
mental health, survival, functioning as adult*
KQ5 KQ2
KQ2
False positives,
false negatives Screening test
accuracy: (e.g., sensitivity, specificity,
positive predictive value,
negative predictive value, likelihood ratio)
KQ4
Harms:
any harm
arising
from
treatment
of DD
KQ3 Children age 1-6 diagnosed
with a Dev. Delay
KQ1
Stage I - Screening - KQ1 and KQ2 Stage II - Treatment - KQ3 and KQ4 Stage III - Test Properties - KQ5
Stage I: Screening
KQ1. What is the effectiveness of screening children aged 1 to 4
years without suspected DD to improve outcomes?
a. What is the optimal interval for screening for DD
Outcomes of interest:
Process outcomes: referral rates for early intervention; time to
referral to early intervention;
Clinical outcomes: cognitive function; academic performance;
incidence of mental health conditions; overall quality of life;
survival; functionality as an adult
KQ2. What is the incidence of harms of screening children aged 1
to 4 years without suspected DD?
15
Eligible Study Types: Screening KQ1 & KQ2
Population: children aged 1-4 years of age not at high risk* or suspected
of having DD. * High risk has been defined as those born prematurely (gestational age less than 37
completed weeks at birth) or with low birth weight (birth weight less than 2,500 g)
and/or children with other known disorders that may be associated with or affect
development.
Intervention: developmental screening tools
Comparator: no screening/ standard care
Study type: Randomized control trials (RCTs), controlled trials,
controlled cohort studies, with at least 6 months of follow-up data from
baseline
Setting: primary care or public health setting
Outcomes: patient important outcomes and the scales used to measure
such outcomes were based on those selected and prioritized by
Canadian clinicians and policymakers (clinical and process outcomes)
Language: English, French
•
16
Stage II: Treatment
KQ3. What is the effectiveness of treatment for children diagnosed
with DD to improve outcomes?
Outcomes of interest:
Clinical outcomes: cognitive function; academic performance;
incidence of mental health conditions; overall quality of life;
survival; functionality as an adult; and improvement to gross
and fine motor skills, language, adaptive functioning, and
cognition and performance (for domain specific delays)
KQ4.What is the incidence of harms of treatment for children
diagnosed with DD?
17
Eligible Study Types: Treatment KQ3 & KQ4
Population: Children aged 1 to 6 diagnosed with domain specific
developmental delay (DD) in one or more of the domains (gross and
fine motor skills; speech and language; social and personal activities
of daily living; performance and cognition).
* Treatment intervention had to have been initiated between the ages of 1-6 years.
Interventions: any behavioral, psychological, or pharmacological
Comparator: no treatment or standard care
Study Design and Comparison Groups: Systematic reviews and
RCTs using comparison groups receiving usual care or no intervention
were considered.
Outcomes: patient important outcomes and the scales used to
measure such outcomes were based on those selected and prioritized
by Canadian clinicians and policymakers
Language: English or French.
•
18
Stage III - Test Properties KQ5
KQ5 . What is the sensitivity, specificity, positive and negative
predictive values, and likelihood ratios of the various screening
tests to assess DD in children aged 1 to 4 years who are not
already suspected of having DD?
19
Eligible Study Types – Test Properties KQ5
Population: children aged 1 to 4 without suspected DD
Intervention: any short screening test, tool or questionnaire that could be
administered in a primary care setting or currently in use in Canada: – Ex. Ages and Stages Questionnaire (ASQ);); Parents’ Evaluation of Developmental
(PEDS); Nipissing District Developmental Screen (NDDS);
Study design: RCTs, cohort and case-control studies; Index and reference tests
administered concurrently or within a brief time interval;
Reference Standard: clinical or diagnostic evaluations using:
– Ex. Bayley Scale of Infant Development (BSID) or BSID-II; Wechsler Preschool and
Primary Scale of Intelligence (WPPSI); Vineland Adaptive Behavior Scale (VABS);
Language: English or French
Exclusions: prognostic tools, predictive tools, diagnostic tools
20
Contextual Questions
Three Contextual Questions:
• What is the cost-effectiveness and feasibility of screening for DD
in children aged 1- 4?
• What are parent/care givers values and preferences for
screening?
• What is the evidence for higher burden of disease, differential
performance for screening and/or treatment response for DD or
barriers to implementation of screening in subgroups
21
How is Evidence Graded?
The “GRADE” System:
• Grading of Recommendations, Assessment, Development & Evaluation
What are we grading?
1. Quality of Evidence
– Degree of confidence that the available evidence correctly reflects the
theoretical true effect of the intervention or service.
– high, moderate, low, very low
2. Strength of Recommendation
– the balance between desirable and undesirable effects; the variability
or uncertainty in values and preferences of citizens; and whether or
not the intervention represents a wise use of resources.
– strong and weak
22
How is the Strength of Recommendations
Determined?
The strength of the recommendations
(strong or weak) are based on four
factors:
• Quality of supporting evidence
• Certainty about the balance
between desirable and
undesirable effects
• Certainty / variability in values and
preferences of individuals
• Certainty about whether the
intervention represents a wise use
of resources
23
Interpretation of Recommendations
Implications Strong Recommendation Weak Recommendations
For patients • Most individuals would
want the recommended
course of action;
• only a small proportion
would not.
• The majority of individuals in this
situation would want the suggested
course of action but many would
not.
For clinicians • Most individuals should
receive the intervention.
• Recognize that different choices will
be appropriate for individual
patients;
• Clinicians must help patients make
management decisions consistent
with values and preferences.
For policy
makers
• The recommendation can
be adapted as policy in
most situations.
• Policy making will require
substantial debate and involvement
of various stakeholders.
24
Evidence: Screening for DD
• One moderate quality American study (n=2,103) measured whether screening
for DD improves time to referral, percentage of early referrals, and eligibility
for early intervention services (process outcomes) – Compared children screening (with and without office support) using ASQ-II at 9, 18, 30 months
and M-CHAT at 18 & 24 months with usual care (age appropriate milestones were assessed at
well child visits)
* NB early intervention refers to programs offered in the US as part of American Individuals with Disability
Education Act, intended to ensure that children with disabilities have access to free individualized public education
programs and interventions. Due to potential differences in legislation and the availability of programs and services in
different countries results related to early intervention may not be generalizable.
26
Evidence: Screening for DD
• One low quality cluster RCT conducted in the Netherlands reported on academic
outcomes of children screened for language delay
• Compared outcomes at 8 years of age for children screened at 15-18 months
and 24 months using the VroegTijdige Onderkenning Ontwikkelingsstoornissen
(VTO) Language Screening instrument with control group (standard care) – Post-screening, the study did not offer an intervention and did not indicate whether children
received interventions elsewhere
– no significant differences in educational attainment between children
identified with language delay through screening or through usual care (no
screening).
• RR 0.99 for repeating a grade (95% CI 0.81, 1.21)
– Little difference in performance on standardized tests between screened and
non-screened children
• RR 0.88 for performance on oral tests <10th percentile (95% CI 0.63, 1.2)
• RR 1.00 (95% CI 0.72, 1.40) for reading tests <10th percentile
– Some difference in performance on standardized spelling test
• RR 0.68 (95% CI 0.41 to1.13) for spelling tests <10th percentile
27
Evidence: Treatment of DD
• 3 structured language-based interventions (n=239 total) for children with
speech/language impairments offered some improvement
– Standard Mean Difference (SMD) of 0.81 [95%CI 0.02, 1.60]
• 2 systematic reviews examining intensive behavioural interventions improved
cognitive function in children with known DD due to ASD
– Applied Behavioural Analysis (n=129) showed an SMD of 1.34 (0.60, 2.08))
– Early Intensive Behavioural Intervention (n=172) showed an SMD of 0.76
(95% CI 0.04 to 1.11).
• 1 systematic review of parent-mediated interventions had no effect on cognitive
outcomes
• No harms from treatment identified
• Treatment findings based on non-screen detected DD
• No studies identified that reported on treatment outcomes for academic
performance, fine and/or gross motor skills, mental health, adaptive function,
social skills, survival, or functionality as an adult
28
Evidence: Treatment of DD
• CTFPHC also reviewed evidence from 5 systematic reviews on
treatment for ASD
29
Evidence: Diagnostic Accuracy of Screening Tests1
• Commonly used screening tests were found to have inconsistent accuracy and
moderate to low specificity
• Ages and Stages Questionnaire (ASQ) – n= 331 children (34 cases, 297 non-cases) aged 12 to 60 months without a
documented history of DD in general primary care settings
– sensitivity 82%; specificity 78% (22% false positive rate)
– n= 565 children (13 cases) aged 18 to 42 months
– sensitivity of 62%; specificity of 84% (16% false positive rate)
• Parents’ Evaluation of Developmental Status (PEDS) – n= 331 children (34 cases, 297 non-cases) aged 12 to 60 months
– sensitivity 74%; Specificity 64% (36% false positive rate)
• Nipissing District Development Screen (NDDS) – n= 812 (31 cases)
– moderate re-test reliability (78%)
– sensitivity 29-63%; specificity 65-88% (12-35% false positive rate)
– varies based on age and cut-points used
• currently no peer reviewed studies on NDDS
1 based on reports from the primary studies
30
Summary: Harms & Benefits of Screening
• Lack of RCT evidence demonstrating any clinical benefits
associated with screening for DD
• Possible harms related to screening include:
– False positives among children without DD
– Anxiety and labelling among children without DD
– The cost of conducting unnecessary medical care (e.g.,
investigation, referral, treatment)
31
Summary Harms & Benefits of Treatment
• Some evidence suggesting that treatment of certain types of DD
is beneficial compared with no treatment
– there was no evidence that screening was necessary to
obtain this benefit
32
Evidence: Contextual Questions
• The systematic review was unable to locate any studies
reporting on parents values, preferences or willingness to have
their children screened
• No evidence reporting on the cost-effectiveness and feasibility
of screening for DD in children was identified in the evidence
review
• The evidence review did not find any studies reporting on higher
burden of disease, differential performance for screening and/or
treatment response for DD or barriers to implementation of
screening in subgroups
33
Values and Preferences
• The evidence review did not find any studies
investigating the values and preferences of parents
or primary caregivers about screening for
Developmental Delay.
34
CTFPHC Recommendation:
Recommendation: We recommend against screening for
developmental delay using standardized tools in children aged 1 to
4 years with no apparent signs of DD and whose parents and
clinicians have no concerns about development
Strong recommendation; low quality evidence
This recommendation applies to children* aged 1 to 4 years with no apparent
signs of DD and whose parents or clinicians have no concerns about
development.
*These are children whose age-appropriate developmental milestones have been
sequentially acquired for gross and fine motor, social/emotional, language, and
cognitive domains. Milestone ages should be based on the oldest age by which the
skill should have been achieved.
This recommendation does not apply to children who present with signs,
symptoms, or parental concern that could indicate developmental delay; or
whose development is being closely monitored because of identified risk factors
such as premature birth or low birth weight.
35
Basis for the recommendation
• No evidence from RCTs that screening children for developmental delay improves health
outcomes
• No evidence that screening tools would consistently identify otherwise unrecognized cases
• Evidence that the low specificity would lead to a high number of false positive tests
• CTFPHC places a relatively higher value on the absence of evidence showing that
screening is beneficial, the poor diagnostic accuracy of screening tests, the risk of false
positives that could result from screening, and the potential for screening to divert resources
from the treatment of children with clinically evident DD
• The CTFPHC places a relatively lower value on the few relatively small studies that suggest
a benefit of treating certain forms of clinically evident DD, and on the lack of evidence on
harms and parents/caregivers preferences and values in relation to screening
• The evidence supporting this recommendation is rated overall as low quality:
– The systematic review found low quality evidence examining the effect of screening on academic
performance; and no evidence reporting on the other clinical outcomes
– A small number of moderate quality studies examining the effect of treatment on language
impairment and cognition
– The review did not identify any evidence for the remaining 6 outcomes: improvement to gross and
fine motor skills, adaptive functioning, incidence of mental health conditions, overall quality of life,
survival, and functionality as an adult.
36
Research Gaps
• High quality studies examining the benefits of screening for DD
and the long-term effectiveness of treatment are lacking
• Rigorous, controlled studies evaluating the effects of various
treatment programs for children with known DD should be an
urgent priority
• Further research to needed to determine the most effective
methods and tools for identifying DD
37
38
Comparison of Other Guidelines
Source Recommendation
CTFPHC, 1994 Recommended assessing developmental milestones at each visit.
Recommended against the use of Denver Developmental Screening Test;
Insufficient evidence to support the inclusion or exclusion of other
screening instruments
Canadian Paediatric
Society, 2011
Recommends screening for DD using a standardized tool such as NDDS at
18 month well baby visit
USPSTF, 2015 Insufficient evidence to assess the balance of benefits and harms of
screening for screening for Speech & Language Delay
USPSTF, 2016 ASD Guideline - insufficient evidence to assess the balance of benefits and
harms of screening for screening for ASD
American Academy of
Pediatrics, 2016 (2006)
Recommends screenings for DD using a standardized screening tool at 9,
18 and 30 month pediatric visits; screening for ASD at 18, 24 months
NICE (UK), 2011 No guidance on developmental delay; recommends against population-
based screening for autism spectrum disorder
SIGN (Scotland), 2007
No guidance on developmental delay; population-based screening for
autism spectrum disorder is not recommended.
Implementation in Practice
• Clinicians should continue ongoing monitoring of development
including:
– identifying risk factors for DD (e.g., low birth weight, family history of DD)
– remaining alert to any social, economic or environmental factors (e.g.,
maternal education, mental illness, neglect)
– talking with parents about their child’s development and eliciting any
parental concerns
– being alert to signs of DD (i.e., delays in a developmental domain)
• Clinicians should proceed with case finding for children they
believe may be at risk of DD
• Clinicians should proceed with clinical evaluation when possible
signs of DD are detected in individual patients
– referring children for specialist evaluation as clinically indicated
40
Knowledge Translation Tools
• The CTFPHC creates KT tools to support the
implementation of guidelines into clinical practice
• A clinician FAQ has been developed for the
developmental delay guideline.
• After the public release, these tools will be freely
available for download in both French and English on
the website: www.canadiantaskforce.ca
41
Key Points
• CTFPHC recommends against screening for developmental delay using
standardized tools in children aged 1 to 4 years with no apparent signs of
DD and whose parents and clinicians have no concerns about
development. Strong recommendation; low quality evidence
– No RCT evidence to suggest that population-based screening for developmental
delay (DD) improves health outcomes
– No evidence that screening tools would consistently identify otherwise unrecognized
cases; there is evidence that low specificity would lead to high proportion of false
positive tests
– High-quality RCT evidence on treatment for known DD is lacking; A few small trials
suggest that speech and language therapy may improve language impairment and
that treatment of autism may improve cognitive function
• Primary care providers are encouraged to continue with standard clinical
practice, including the identification of risk factors for DD, being alert to signs
and symptoms of DD, and eliciting any parental concerns about development
• Clinicians should proceed with case finding for children they believe may be at
risk of DD and clinical evaluation when possible signs of DD are detected in
individual patients
43
Conclusions
• The CTFPHC recommends physicians to remain vigilant in
monitoring a child’s development at each clinical encounter and
focus on confirming the diagnosis of DD among children in
whom it is suspected
• Studies examining the benefits of screening for developmental
delay and the long-term effectiveness of treatment are lacking
• Studies evaluating the best ways to treat children with known
DD should be an urgent priority –especially given the promising
findings about the potential benefits of treating diagnosed DD
44
Update: CTFPHC Mobile App Now
Available
• The app contains guideline
and recommendation
summaries, knowledge
translation tools, and links to
additional resources.
• Key features include the ability
to bookmark sections for easy
access, display content in
either English or French, and
change the font size of text.
45
More Information
For more information on the details of this guideline
please see:
• Canadian Task Force for Preventive Health Care
website: http://canadiantaskforce.ca/?content=pcp
46